Bariatric Surgery, Gastrointestinal Symptoms, Intestinal Permeability, Metabolic Syndrome, Obesity, Morbid
Conditions
Keywords
Laparoscopic Sleeve Gastrectomy, Zonulin, Secretory IgA, Lipopolysaccharide, GSRS, Body Weight Management, Gut microbiota, Postoperative Metabolic Parameters
Brief summary
This study aims to evaluate the changes in metabolic parameters, intestinal permeability, and gastrointestinal symptoms in individuals who have undergone bariatric surgery (Laparoscopic Sleeve Gastrectomy - LSG) for obesity treatment. Obesity is a chronic disease associated with serious health complications including type 2 diabetes, hypertension, cardiovascular disease, and metabolic disorders. Bariatric surgery is currently the most effective treatment method for morbid obesity. However, monitoring patients after surgery in terms of metabolic health, gut permeability, and gastrointestinal symptoms is crucial for long-term success. In this study, 40 volunteers (aged 19-50) who have undergone LSG surgery within the last month will be followed for 6 months. At the beginning of the study and 6 months later, the following will be assessed: * Metabolic parameters: fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) cholesterol, and insulin levels * Intestinal permeability markers: zonulin, secretory immunoglobulin A (IgA), and lipopolysaccharide (LPS) levels * Gastrointestinal symptoms: assessed using the Gastrointestinal Symptom Rating Scale (GSRS) * Anthropometric measurements: body weight, height, waist and hip circumference, BMI * Nutritional intake: 3-day dietary records The study will be conducted at Bursa Yıldırım Doruk Hospital, General Surgery Clinic. Results will contribute to understanding the relationship between bariatric surgery and gut health, potentially helping to prevent postoperative complications.
Detailed description
Obesity is defined by the World Health Organization (WHO) as abnormal or excessive fat accumulation that presents a risk to health. Bariatric surgery, particularly Laparoscopic Sleeve Gastrectomy (LSG), is considered the most effective long-term treatment for morbid obesity. This prospective observational study will be conducted at Bursa Yıldırım Doruk Hospital with 40 volunteers who have undergone LSG within the last month. Participants will be evaluated at baseline (immediately after surgery) and at 6 months post-surgery. Assessments include: 1. Anthropometric Measurements: Body weight, height, waist and hip circumference will be measured. BMI and waist-to-hip ratio will be calculated according to WHO criteria. 2. Biochemical Parameters: Fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) cholesterol, and insulin levels will be obtained from patient records. Zonulin, secretory immunoglobulin A (IgA), and lipopolysaccharide (LPS) levels will be analyzed using ELISA method (Biotek TS800) with commercial kits (RelAssay® Diagnostics, Ankara, Turkey) at Ankara Diagen Laboratory. Samples will be stored at -20°C until analysis. 3. Gastrointestinal Symptom Rating Scale (GSRS): A validated 15-item scale assessing five dimensions: diarrhea, indigestion, constipation, abdominal pain, and reflux. Scores range from 1 (no discomfort) to 7 (very severe discomfort). Turkish validity and reliability was established by Turan and Asti (2011). 4. Dietary Assessment: 3-day dietary records will be collected and analyzed using the Nutrition Information System (BeBIS) 8.2 software. Results will be evaluated according to the Turkish Dietary Guidelines 2022 (TUBER 2022). Statistical analyses will be performed using the Statistical Package for the Social Sciences (SPSS) 22.0. Normal distribution will be assessed using Kolmogorov-Smirnov/Shapiro-Wilk tests. Results will be expressed as mean ± standard deviation for continuous variables and frequency/percentage for categorical variables.
Interventions
Participants will undergo two assessment visits: at baseline (within 1 month post-surgery) and at 6-month follow-up. Each visit includes anthropometric measurements (body weight, height, waist and hip circumference, BMI), biochemical blood analysis (fasting glucose, lipid profile, insulin, zonulin, secretory IgA, LPS), gastrointestinal symptom evaluation via GSRS, and 3-day dietary records.
Sponsors
Toros University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last 1 month * Aged between 19-50 years * BMI ≥40 kg/m² or BMI ≥35 kg/m² with obesity-related comorbidities * Signed informed consent form * Non-smoker and non-alcohol dependent
Exclusion criteria
* Did not undergo or is not planned to undergo LSG * Outside the age range of 19-50 years * Did not sign the informed consent form * BMI \<40 kg/m² or BMI \<35 kg/m² without obesity-related comorbidities * Smoker or alcohol dependent * Has an inflammatory disease * Currently using probiotics, antibiotics, or fiber supplements * Has a psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Blood Glucose Concentration (mg/dL) | Baseline and 6 months | Change in serum fasting blood glucose levels after 12-hour fasting between baseline and 6-month follow-up. |
| Change in Total Cholesterol Concentration (mg/dL) | Baseline and 6 months | Change in serum total cholesterol levels after 12-hour fasting between baseline and 6-month follow-up. |
| Change in Triglyceride Concentration (mg/dL) | Baseline and 6 months | Change in serum triglyceride levels after 12-hour fasting between baseline and 6-month follow-up. |
| Change in HDL Cholesterol Concentration (mg/dL) | Baseline and 6 months | Change in serum high-density lipoprotein (HDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up. |
| Change in LDL Cholesterol Concentration (mg/dL) | Baseline and 6 months | Change in serum low-density lipoprotein (LDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up. |
| Change in VLDL Cholesterol Concentration (mg/dL) | Baseline and 6 months | Change in serum very low-density lipoprotein (VLDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up. |
| Change in Fasting Insulin Concentration (µIU/mL) | Baseline and 6 months | Change in serum fasting insulin levels after 12-hour fasting between baseline and 6-month follow-up. |
| Change in Serum Zonulin Concentration (ng/mL) | Baseline and 6 months | Change in serum zonulin levels assessed by ELISA method between baseline and 6-month follow-up. |
| Change in Serum Secretory IgA Concentration (mg/dL) | Baseline and 6 months | Change in serum secretory IgA levels assessed by ELISA method between baseline and 6-month follow-up. |
| Change in Serum LPS Concentration (EU/mL) | Baseline and 6 months | Change in serum lipopolysaccharide (LPS) levels assessed by ELISA method between baseline and 6-month follow-up. |
| Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score (1-7) | Baseline and 6 months | Change in total score of the Gastrointestinal Symptom Rating Scale (GSRS) between baseline and 6-month follow-up. The scale consists of 15 items across 5 subscales; scores range from 1 to 7, with higher scores indicating more severe gastrointestinal symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (kg) | Baseline and 6 months | Change in body weight between baseline and 6-month follow-up. |
| Change in Body Mass Index (kg/m²) | Baseline and 6 months | Change in BMI between baseline and 6-month follow-up. Weight and height will be combined to report BMI in kg/m². |
| Change in Waist Circumference (cm) | Baseline and 6 months | Change in waist circumference between baseline and 6-month follow-up. |
| Change in Hip Circumference (cm) | Baseline and 6 months | Change in hip circumference between baseline and 6-month follow-up. |
| Change in Waist-to-Hip Ratio | Baseline and 6 months | Change in waist-to-hip ratio between baseline and 6-month follow-up. Waist and hip circumference measurements will be combined to calculate the waist-to-hip ratio. |
| Change in Daily Energy Intake (kcal/day) | Baseline and 6 months | Change in daily energy intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software. |
| Change in Daily Protein Intake (g/day) | Baseline and 6 months | Change in daily protein intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software. |
| Change in Daily Carbohydrate Intake (g/day) | Baseline and 6 months | Change in daily carbohydrate intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software. |
| Change in Daily Fat Intake (g/day) | Baseline and 6 months | Change in daily fat intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBetül GÜLŞEN, Assoc. Prof.
CONTACTÖzlem ÖZPAK AKKUŞ, Assoc. Prof.
PRINCIPAL_INVESTIGATORBetül GÜLŞEN, Assoc. Prof.
Toros University
STUDY_CHAIRÖzlem ÖZPAK AKKUŞ, Assoc. Prof.
Toros University
STUDY_DIRECTORDoğukan DURAK, Assoc. Prof.
Bursa Yıldırım Doruk Hospital, General Surgery Clinic
Outcome results
None listed